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Electric Scooters
EUDAMEDFDA UDIClass I (EU MDR)
Ref SM4141
by Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.
Identity
- Trade Name
- Lerado FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- Electric Scooters EUDAMED
- Model / Reference
- SM4141 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973134780060 EUDAMEDFDA UDI
- Basic UDI-DI
- 697313478PS001HT EUDAMED
- Direct Marketing DI
- 06973134780060 EUDAMED
- 510(k) Number
- K051473 FDA UDI
- FDA Product Code
- INI FDA UDI
- EMDN Code
- Y122124 ELECTRIC SCOOTERS EUDAMED
- GMDN Term
- Assistive scooter, electric-motor-driven FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Electric Scooters by Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697313478PS001HT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000012010
- Authorised Representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Sources (2)
- EUDAMED 182afd20-3fcf-4193-9667-6acb20d1644a 61 fields · synced Jul 27, 2026
- FDA UDI b62ede7f-7883-441b-91ec-fafa3ef462fe 33 fields · synced May 29, 2026